Alprazolam vs Diazepam: side effects in FDA adverse event reports
At a glance
| Alprazolam | Diazepam | |
|---|---|---|
| Drug class | Benzodiazepine | Benzodiazepine |
| Brand names | – | – |
| FAERS reports | 204,870 | 120,964 |
| Serious | 71% | 81% |
| Death outcome | 33,446 | 22,961 |
| Boxed warning | Yes RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids ma | Yes WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and |
Signals both drugs share
| Reaction | Alprazolam | Diazepam | Label screen (A / B) |
|---|---|---|---|
| Coma | 2,872 · PRR 6.5 | 3,231 · PRR 12.5 | Labeled — boxed warning / Labeled — boxed warning |
| Poisoning | 1,659 · PRR 15.4 | 1,201 · PRR 18.2 | Labeled adverse reaction / Not in label — unassessed |
| Drug use disorder | 951 · PRR 13.2 | 1,142 · PRR 27.6 | Labeled (related wording) / Labeled (related wording) |
| Substance use disorder | 283 · PRR 10.3 | 790 · PRR 59.8 | Labeled adverse reaction / Labeled adverse reaction |
| Multiple drug overdose intentional | 312 · PRR 10.7 | 205 · PRR 11.6 | Labeled (related wording) / Not in label — unassessed |
| Sopor | 2,105 · PRR 19.0 | 809 · PRR 11.1 | Not in label — unassessed / Not in label — unassessed |
| Poisoning deliberate | 1,439 · PRR 18.6 | 1,162 · PRR 24.6 | Not in label — unassessed / Not in label — unassessed |
| Miosis | 512 · PRR 7.0 | 1,012 · PRR 25.1 | Not in label — unassessed / Not in label — unassessed |
| Multiple drug overdose | 480 · PRR 10.7 | 462 · PRR 17.4 | Not in label — unassessed / Not in label — unassessed |
| Bradypnoea | 255 · PRR 10.6 | 483 · PRR 37.9 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 450 · PRR 10.8 | 266 · PRR 10.4 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 242 · PRR 10.7 | 153 · PRR 11.1 | Not in label — unassessed / Not in label — unassessed |
| Accidental death | 173 · PRR 10.4 | 188 · PRR 19.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Alprazolam
- Suicide attempt — n=3,736, PRR 6.6 Labeled (related wording)
- Bradyphrenia — n=447, PRR 7.4 Labeled adverse reaction
- Suspected suicide — n=325, PRR 7.4 Labeled (related wording)
- Rebound acid hypersecretion — n=252, PRR 9.1 Labeled (related wording)
- Anxiety disorder — n=199, PRR 6.4 Labeled (related wording)
Labeled signals distinctive to Diazepam
- Respiratory depression — n=1,038, PRR 16.0 Labeled — boxed warning
- Alcohol interaction — n=127, PRR 12.0 Labeled (related wording)
Common questions
Which has more reported side effects, Alprazolam or Diazepam?
Alprazolam has 204,870 FAERS reports and Diazepam 120,964. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (71% vs 81%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Alprazolam and Diazepam share?
Both drugs carry disproportionality signals for coma, poisoning, drug use disorder, substance use disorder, multiple drug overdose intentional. Shared signals often reflect a shared drug class or the condition both are used for.
Is Alprazolam or Diazepam safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.